clorazepate (Tranxene SD, Tranxene T-Tab)

Dosing and uses of Tranxene SD, Tranxene T-Tab (clorazepate)

• Adult
• Pediatric
• Geriatric

 

Adult dosage forms and strengths

tablet: Schedule IV

• 3.75mg
• 7.5mg
• 15mg

 

Anxiety

30 mg/day PO in divided doses; adjust dose gradually within range of 15-60 mg/day

When administered as single daily HS dose, initial dosage is 15 mg; after initial dose, response of patient may require subsequent dosage adjustment

 

Seizure

7.5 mg PO q8hr; increase by < 7.5 mg/week; 90 mg/day maximum

 

Acute Alcohol Withdrawal

Day 1: Initial 30 mg PO once, THEN 30-60 mg in divided doses, no more than 90 mg

Day 2: 45-90 mg PO in divided doses

Day 3: 22.5-45 mg PO in divided doses

Day 4: 15-30 mg PO in divided doses

Day 5 onwards: 7.5-15 mg PO in divided doses

Discontinue when stable

 

Pediatric dosage forms and strengths

tablet: Schedule IV

• 3.75mg
• 7.5mg
• 15mg

 

Partial Seizures

<9 years: Not recommended

9-12 years: 7.5 mg PO BID initially; increase by <7.5 mg qWeek to 60 mg/day maximum

>12 years: As in adults

 

Geriatric dosage forms and strengths

Not drug of choice in elderly because of long-acting metabolite; long-acting benzodiazepines associated with falls in elderly

 

Anxiety

7.5 mg PO qDay or q12hr

 

Tranxene SD, Tranxene T-Tab (clorazepate) adverse (side) effects

Frequency not defined

Drowsiness

Dizziness

Nervousness

Headache

Confusion

GI complaints

Dry mouth

Blurred vision

 

Warnings

Contraindications

Documented hypersensitivity

Breastfeeding

Narrow-angle glaucoma

 

Caution

Anterograde amnesia may occur

May cause CNS depression

May experience aggressive behavior

Caution in patients with a history of drug abuse; tolerance, psychological, and physical dependence may occur with prolonged use

Caution in patients with gag reflex

Caution in patients with respiratory disease

Caution in hepatic impairment

 

Pregnancy and lactation

Pregnancy category: Not available. An increased risk of congenital malformations associated with the use of minor tranquilizers during the first trimester of pregnancy has been suggested in several studies. Pregnant patients taking clorazepate should enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. More information can be found at https://www.aedpregnancyregistry.org

Lactation: enters breast milk; do not nurse

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Tranxene SD, Tranxene T-Tab (clorazepate)

Mechanism of action

Enhances the inhibitory effect of GABA on neuronal excitability by increasing neuronal membrane permeability to chloride ions

 

Pharmacokinetics

Half-Life: 50-70 hr

Time to peak: ~ 1 hr

Protein Bound: 97-98%

Metabolism: Hydroxylation, glucuronic acid conjugation

Metabolites: Desmethyldiazepam (nordiazepam), oxazepam

Excretion: Urine

Onset of action: 1-2 hr

Duration: Variable 8-24 hr